Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria

PHASE2/PHASE3TerminatedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 21, 2020

Primary Completion Date

July 2, 2023

Study Completion Date

May 10, 2024

Conditions
Plasmodium Falciparum Malaria
Interventions
DRUG

artemether:lumefantrine (2.5 mg:30 mg)

Two oral dispersible tablets twice daily for three consecutive days. Each tablet contained artemether-lumefantrine 2.5 mg:30 mg.

Trial Locations (3)

Unknown

Novartis Investigative Site, Nanoro

Novartis Investigative Site, Ouagadougou

Novartis Investigative Site, Kisantu

Sponsors
All Listed Sponsors
collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

collaborator

Medicines for Malaria Venture

OTHER

collaborator

Groupe de Recherche Action en Sante

OTHER

collaborator

Institut de Recherche en Sciences de la Sante, Burkina Faso

OTHER_GOV

lead

Novartis Pharmaceuticals

INDUSTRY